January 2018

FDA Approves Marketing of Device to Treat DFUs

In December 2017, the U.S. Food and Drug Administration (FDA) approved the marketing of Sanuwave’s dermaPACE System, the first shock-wave device to treat diabetic foot ulcers (DFUs). The system uses externally applied energy pulses, similar to sound waves, to mechanically stimulate the wound. It is intended to be used in the treatment of chronic, full-thickness DFUs with wound areas measuring no larger than 16 cm2 that extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The device is intended for patients 22 years and older, who present with DFUs lasting longer than 30 days, and should be used along with standard diabetic ulcer care.

The FDA reviewed clinical data from two multicenter, randomized, double-blind studies with a total of 336 diabetic patients receiving either usual care, which includes wet-to-dry dressings or debridement as needed, plus the Dermapace System, or usual care plus non-working shock wave therapy. Both patient groups included those with poorly controlled and well-controlled blood glucose levels. Patients who had between one and seven treatments with the Dermapace System showed an increase in wound healing at 24 weeks, with a 44 percent wound closure rate. Patients treated with the sham shock wave therapy showed a 30 percent wound closure rate during the same period.

The most common side effects were pain during application of the device, local bruising and numbness, migraines, nausea, fainting, wound infection, infection beyond the wound (cellulitis, osteomyelitis), and fever.